What is the minimum classification for a Secondary Engineering Control (SEC)?

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The minimum classification for a Secondary Engineering Control (SEC) is ISO 7. This standard is critical in ensuring that the environment where compounding takes place provides a controlled level of cleanliness to protect the integrity of compounded sterile preparations. ISO 7 provides specific limits on particulate contamination, air cleanliness, and other environmental factors that must be maintained to safeguard patient health and reduce the risk of contamination.

An SEC is designed to support the proper functioning of the primary engineering control (such as a laminar airflow hood or biological safety cabinet) by providing a higher level of environmental control over the entire compounding area. By mandating a minimum of ISO 7, regulations ensure that the risk factors associated with compounded sterile products are adequately managed, reflecting the need for a clean environment that reduces the likelihood of microbial contamination.

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